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Clarification on 507.208 Requirements for Record Retention

FSMA Preventive Controls FDA

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#1 MsMars

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Posted 18 January 2019 - 03:32 PM

I'm having trouble interpreting 507.208 Requirements for record retention. 

 

 

 

© Except for the food safety plan, offsite storage of records is permitted if such records can be retrieved and provided onsite within 24 hours of request for official review. The food safety plan must remain onsite. Electronic records are considered to be onsite if they are accessible from an onsite location.

 

Does this mean only "records" are permitted to be electronic, or can my food safety plan be accessible electronically as well?

 

Records are not defined in the definitions. 

 

 



#2 kfromNE

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Posted 18 January 2019 - 06:08 PM

You can use paper versions or electronic records- either one is acceptable.  This is clarifying what it means to be on-site for an electronic version. For example if your complete food safety plan is on the laptop of the CEO whose computer isn't always onsite or if the plan is stored on an external hard drive that isn't in the building - these are not allowed. If the food safety plan is stored on for example Dropbox and someone onsite has access to it from a computer - that would be considered on-site and allowed.



#3 kfromNE

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Posted 18 January 2019 - 06:23 PM

Here's an article that explains records really well.

 

https://www.qualitya...rds-importance/



#4 MsMars

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Posted 18 January 2019 - 06:43 PM

I understand that I can keep records related to the program electronically.  But can I keep our hazard analysis off-site and upload electronically? The phrase at the beginning "Except for the food safety plan" and "The food safety plan must remain onsite" is throwing me off. Does Food Safety Plan fall under the definition of records? 



#5 Scampi

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Posted 18 January 2019 - 06:59 PM

The food safety plan would not be considered a record. the food safety plan is a program/policy

 

It is the HA, the flow diagram, CCP determinations etc etc


Because we always have is never an appropriate response!


#6 MsMars

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Posted 18 January 2019 - 07:42 PM

The food safety plan would not be considered a record. the food safety plan is a program/policy

 

It is the HA, the flow diagram, CCP determinations etc etc

 

That's what I've always thought too.  However, the way the FDA has this worded/sequenced in the regulation has me scratching my head over whether or not I can keep it offsite but electronically accessible.  


Edited by MsMars, 18 January 2019 - 07:43 PM.


#7 Scampi

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Posted 18 January 2019 - 07:47 PM

I wouldn't MsMars

 

Let's say they question your CCP determine (as an example) it's much faster to retrieve your validation and program in paper than it is to download and print off

for your sake, keep a paper copy in a binder on site, even if you watermark them as duplicates  

 

You oversee the QA from afar?


Because we always have is never an appropriate response!


#8 John_E

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Posted 18 January 2019 - 09:48 PM

Why would you not keep it in paper format on site?



#9 MsMars

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Posted 18 January 2019 - 09:57 PM

I oversee several facilities - one on the same campus with shared office, but also a small one in a nearby but different town.  In a past life all facilities were on one plan maintained at this central office, although all the facilities have different equipment and processes.  Since I've been on board, I've separated the flow charts and hazard analyses for obvious reasons.  The facility in a different town is still managed from this office. It will share most of the same SOPs, policies, and forms, all of which are available via file-sharing system.  I do also plan on keeping a controlled printed copy of the food safety manual there.  I just wasn't sure how necessary it was to also include the hazard analysis and flow charts (i.e. the food safety plan). I've always liked to keep the plan semi-confidential and I don't like having printed copies floating around that I can't supervise. 


Edited by MsMars, 18 January 2019 - 09:58 PM.


#10 Scampi

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Posted 21 January 2019 - 01:57 PM

I understand that last sentence completely!  Anyway you can request a lockbox to store them?  


Because we always have is never an appropriate response!


#11 MsMars

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Posted 21 January 2019 - 05:33 PM

I understand that last sentence completely!  Anyway you can request a lockbox to store them?  

 

Yes I was thinking along those lines... or a locked cabinet. 







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